What are the responsibilities and job description for the Product Certification Safety- Electrical Engineer position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
- Support development including planning, communicating periodic status and known risks (with proposed solutions) on the projects to R&D core teams.
- Capable of performing safety testing and of Client products in the Client safety Lab and external labs.
- Prepare documentation to execute safety certification activities - Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms.
- Communicate with internal / external labs, technicians, and design engineers to accomplish timely / valuable results at optimal cost (from Quote request to final deliverables).
- Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals.
- Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety verification test plans and test reports.
Requirements :
